efficacy and safety of oral semaglutide versus liraglutide and versus placebo in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of this trial is to investigate efficacy and safety of oral semaglutide versus liraglutide and versus placebo in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * male or female, age above or equal to 18 years at the time of signing informed consent. for japan only: male or female, age at least 20 years at the time of signing informed consent * diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening. * hba1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive) * stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with a stable daily dose of a sglt-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days prior to day of screening (fixed-dose combinations are allowed) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).for certain specific countries: additional specific requirements apply * any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * family or personal history of multiple endocrine neoplasia type 2 (men 2) or medullary thyroid carcinoma (mtc) * history of pancreatitis (acute or chronic) * history of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * any of the following: myocardial infarction (mi), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening * subjects presently classified as being in new york heart association (nyha) class iv * planned coronary, carotid or peripheral artery revascularisation known on the day of screening * subjects with alt (alanine aminotransferase) above 2.5 × upper normal limit (unl) * renal impairment defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m\^2 as per chronic kidney disease epidemiology collaboration formula (ckd-epi) * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. an exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days * proliferative retinopathy or maculopathy requiring acute treatment. verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation * history or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ) * history of diabetic ketoacidosis